Associate Professor Robyn Langham1
Ms Monica Gilbert1
Dr Mike Salzberg1
Professor Danny Liew 2, 3
Professor David Castle1
Dr James Chamberlain1
St Vincent’s Hospital Melbourne 2
University of Melbourne 3
Royal Melbourne Hospital
Award type beyondblue
Victorian Centre of Excellence
Project completion year
Chronic kidney disease is a serious and growing health problem with an enormous impact on social and psychological functioning. Despite high rates of co-morbid depression and anxiety in end stage kidney disease (ESKD), and despite disquieting evidence of their potential effects on treatment adherence, quality of life, intimate relationships, level of disability, medical outcomes, survival and health care costs, very little has been done to prevent or manage these problems. Whether interventions targeted at anxiety and depression have the capacity to reverse such effects in ESKD is at present unknown, but the case for well-designed trials of such interventions is compelling.
The Optimal Health Program (OHP) is a manual individual or group-based program used as a form of treatment to provide knowledge and skills regarding how to optimise health. Participants can gain confidence in their ability to understand the vulnerabilities that impact on their health, recognise stress and choose constructive coping strategies to maintain optimal health. When used within a service, it provides a common language for all staff and consumers to communicate and address health needs. The OHP is an eight-week generic program for people who wish to achieve or maintain optimal health.
In this study, the OHP was delivered to patients with ESKD requiring dialysis and renamed the Dialysis Optimal Health Program (DOHP). The pilot project aimed to deploy DOHP in a sample of ESKD patients in their first year of dialysis, to test its feasibility and to gather necessary logistical data in order to design a definitive randomised controlled trial (RCT). The setting for this pilot study and for the subsequent RCT, the St. Vincent’s Hospital Nephrology Service, is a major centre of academic and clinical excellence for treatment of chronic kidney disease (CKD), comprising the urban hospital base and eight satellite centres, including several rural sites.
The researchers conducted a pilot randomised controlled trial of DOHP in the St. Vincent’s Hospital dialysis service, recruiting patients from both the metropolitan site (the St. Vincent’s Dialysis Centre) and one rural site (Shepparton). Rural patients undergo initial dialysis treatment and training at St. Vincent’s Hospital, prior to returning home for continued therapy, either at home or in a local facility. Subjects were recruited during their initial dialysis training and treatment.
Primary outcomes were measured on depression, anxiety and quality of life. Secondary outcomes were treatment adherence, perceived social support, level of function, episodes of psychiatric illness and treatment, medical morbidity and health care utilisation (outpatient visits, hospitalisation rate).
Recruitment took place over a 12-month period. Patients were informed of the study by a research clinician working in conjunction with the nephrology team. Patients were approached for consent and, if agreeing to participate, were randomised to either treatment arm (DOHP) (n=5) or control, or standard treatment (n=7). At completion of the intervention or control period, they were followed up for a further 10 months (12 months in total).
Description of RCT: treatment and control condition
Participants in the Control condition received routine care, as currently provided by the Nephrology Service. Routine care consists of education by the doctors, nurse, social worker, and/or pre-dialysis educator regarding dialysis therapy, dietary management, fluid intake and medication management.
The Intervention condition consists of treatment as described above and the Dialysis Optimal Health Program (DOHP).
A covariate adaptive method of individual randomisation was developed. The allocation sequence was generated using computer generated random numbers and concealed from clinicians until the patient consented and completed a baseline assessment, while maintaining blinding. This method balanced the treatment and control groups with respect to gender, type of dialysis (haemodialysis or peritoneal) and location (metropolitan or rural). Trialling this procedure on the pilot data demonstrated the feasibility of the randomisation procedure, which would be expected to work well on a larger sample.
Comparison of baseline characteristics of treatment and control group
Treatment and control groups were compared on a range of baseline variables including age, gender, level of education, relationship status and place of residence. There were no significant differences at baseline.
Based on the MINI, no participants had current depression at baseline but one control participant had past history of depression, another had current agoraphobia without panic disorder and another had alcohol dependence.
Depression and anxiety trajectories
Analysis of the incidence of depression and anxiety (using the MINI), based on monthly phone calls after three months post-baseline and the baseline and three month face-to-face assessments, showed some interesting results. In the control group, there were a total of three occasions out of 42 where depression was reported and four occasions out of 43 where anxiety was reported. This contrasts with the treatment group where, on more than 28 occasions, there were no instances of depression or anxiety reported. However, under a null hypothesis, assuming similar variance in the two groups, there was no significant difference using a multivariate permutation test.
In addition, the percentage of occasions each participant reported symptoms of anxiety and depression were analysed. The percentage of occasions with depression averaged over participants was 5.6 per cent for control and zero for treatment. The percentage of occasions with anxiety averaged over participants was 7.4 per cent for control and zero for treatment. Based on permutation tests, these results were not statistically significant.
Summary statistics for the outcome measures for the three monthly assessments were analysed. Based on the linear regression analysis, there were no statistically significant differences between treatment and control. While this null result was not surprising given the small sample size (n=12), the high post-baseline scores for SF36 social functioning for the treatment group are encouraging.
Prevalence data indicate that depression and anxiety are common in people with renal disease. This study would suggest that even healthy subjects initiating dialysis carry a higher risk of developing depression and anxiety at 12 months. As poor compliance is high within this population, co-morbid depression and anxiety can be a significant contributing factor. Further to this, the use of a self-management program such as DOHP alongside medical treatment may potentially ameliorate the expression of these symptoms.